Sodium Restriction in the Management of Cirrhotic Ascites
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Details and patient eligibility
About
To determine the relationship between degree of sodium restriction and dietary compliance with clinical outcome of diuresis of portal hypertensive ascites in cirrhotic patients from a county hospital population.
Primary objective: Demonstrate that, when accompanied by the appropriate diuretic regimen, a No Added Salt diet (4 grams sodium per day) is as effective as a Low Sodium diet (2 grams sodium per day) in the management of cirrhotic ascites.
Full description
Secondary objectives:
- Demonstrate that patient acceptance is greater and diuresis faster with a No Added Salt diet compared with a Low Sodium diet
- Demonstrate that side-effects of diuretic therapy are the same or less when patients are on a No Added Salt diet
- Determine if glomerular filtration rate estimated from the modified diet in renal disease equation differs from that obtained by a 24 hour urinary creatinine in patients with cirrhotic ascites
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Cirrhotic patients of any etiology with ascites from portal hypertension diagnosed by paracentesis,
- Age 18-75
- Clinical or radiographic (abdominal CT or ultrasound) estimate of moderate - severe ascites
- Spanish-speaking subjects will be eligible for participation
Exclusion criteria
- Active drug or alcohol abuse,
- Active complications of SBP, hepatic encephalopathy, or GI bleed within 2 weeks,
- Hemorrhagic ascites, malignant ascites,
- Creatinine >2 mg/dL or CCl < 30 mL/min,
- K > 5.5 mmol/L,
- Diuretic refractory ascites
- Allergy to or intolerance of either spironolactone or furosemide
- Homelessness, incarceration, inability to follow up in clinic, or comply with diet.
Trial design
Primary purpose
Allocation
Interventional model
Masking
68 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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